Removing supra and subgingival calculus deposits and stains from teeth .
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .
Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
Plugging for amalgam condensation .
Amalgam burnishing ●
Preparing, cleaning and irrigating root canals .
Cavity preparation .
. Cementing inlays and onlays
Retrograde preparation of root canals ●

Device Description

The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.

AI/ML Overview

This document is a 510(k) summary for a medical device (EMS Piezon® Master 600) and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving device performance. This type of submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a full clinical trial report with detailed performance metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Electrical Safety Testing	Activities conducted. Results confirm the device is safe.
Electromagnetic Compatibility (EMC)	Activities conducted. Results confirm the device is safe.
Design Control Checklists	Completed to ensure all design requirements were fulfilled.
Overall Safety and Effectiveness	Results confirm the modified device is safe and effective for indicated dental and periodontal procedures.
Substantial Equivalence (to Predicate)	Determined by FDA based on enhanced procedural flexibility and improved ease of use, with no alteration to general intended use or fundamental scientific technology. New applications were cleared for use with another predicate (EMS KERMIT®).

Missing Information:

Specific quantitative acceptance criteria (e.g., maximum leakage current, specific EMC levels).
Detailed quantitative performance data (e.g., cleaning efficiency, scaling precision, time to complete tasks for new applications, vibration characteristics, efficacy rates for specific procedures). The document mentions "enhanced ultrasonic performance" but doesn't provide metrics.

2. Sample Size Used for the Test Set and Data Provenance

This document does not provide a sample size for a test set in the context of clinical or performance data. The "performance testing" referred to (electrical safety, EMC, design control) are engineering and regulatory compliance tests, not typically clinical studies involving patient data.

Missing Information:

Sample size for any test set involving performance on human or animal subjects.
Data provenance (country of origin, retrospective/prospective).

3. Number of Experts and their Qualifications for Ground Truth

This document does not describe the establishment of a ground truth by experts in the way you've outlined for clinical studies. The performance testing mentioned refers to engineering and design verification.

Missing Information:

Number and qualifications of experts for ground truth.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method for a clinical test set, as no such test set is detailed.

Missing Information:

Adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This document does not mention or describe a MRMC comparative effectiveness study. The device is an ultrasonic scaler, suggesting a focus on mechanical performance rather than image interpretation by human readers.

Missing Information:

Information on MRMC study or AI-assisted improvement for human readers.

6. Standalone (Algorithm Only) Performance Study

The device is a physical ultrasonic scaler, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable in this context.

7. Type of Ground Truth Used

For the engineering and design verification tests mentioned, the "ground truth" would be established by engineering standards, regulatory requirements, and internal design specifications. For example, electrical safety is judged against a standard like IEC 60601-1, and EMC against relevant IEC or national standards. These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. Sample Size for the Training Set

This document does not refer to a training set as would be used for an AI/machine learning algorithm. The development of this physical medical device would involve design, prototyping, and iterative testing, but not a "training set" in that context.

Missing Information:

Sample size for a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, this information is not applicable.

Summary of what the document does provide regarding performance and acceptance:

The document describes the device as a modification of a predicate device (Piezon® Master 400). The modifications aimed to enhance procedural flexibility and ease of use, and included "enhanced ultrasonic performance." The basis for substantial equivalence is that these modifications do not alter the general intended use or fundamental scientific technology. New applications (cavity preparation, cementation, retrograde root canal preparation) are covered by equivalence to another predicate device (EMS KERMIT®) which was previously cleared for those uses.

Performance testing was conducted as part of design verification and validation activities. These included:

Electrical safety testing
Electromagnetic compatibility testing (EMC)
Completion of Design Control Checklists to ensure all design requirements were fulfilled.

The results of these engineering/regulatory compliance tests "confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures." The FDA's substantial equivalence determination implies these tests met the necessary acceptance criteria for the device to be marketed.

Summary

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AUG 1 3 2002

Ko22328

Special 510(k): Device Modification 510(k) Summary for Electro Medical Systems SA EMS PIEZON® MASTER 600

1. SPONSOR

ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland

Contact Person: Suzanne Fassio Regulatory Manager

Date Prepared: July 17, 2002

2. Device Name

Trade/Proprietary Name: EMS Piezon® Master 600 Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler

3. Predicate Devices

. Piezon Master 400 (K896749)
EMS KERMIT® (K992504) ●

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INTENDED USE 4.

The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

Removing supra and subgingival calculus deposits and stains from teeth .
Periodontal pocket lavage with simultaneous ultrasonic tip movement .
Scaling and root planing .
Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
Plugging for amalgam condensation .
Amalgam burnishing ●
Preparing, cleaning and irrigating root canals .
Cavity preparation .
. Cementing inlays and onlays
Retrograde preparation of root canals ●

ഗ് DEVICE DESCRIPTION

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The modifications made to the parent Piezon® Master 400 to produce the proposed EMS Piezon® Master 600 were implemented to enhance the procedural flexibility and improve the ease of use of the device. These modifications do not alter the general intended use or fundamental scientific technology of the device.

Both the proposed and parent devices are ultrasonic scalers intended for use in dental and periodontal cleaning, preparatory, and restorative procedures. The capability of the Piezon® Master 600 ultrasonic scaler was enhanced to include the cavity preparation, cementation of inlays and onlays, and retrograde preparation of root canals. These applications were cleared for use with the EMS KERMIT®.

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The overall design of the EMS Piezon® Master 600 is identical to the design of the unmodified Piezon® Master 400. The design modifications made to produce the EMS Piezon® Master 600 were implemented to improve the convenience and ease of use of the device and allow use of the Piezon® Master 600 with all instruments available for the EMS ultrasonic scaler product line. These design enhancements include the following:

. Enhanced ultrasonic performance
Improved handpiece appearance and ergonomics .
. Irrigation liquid flow control moved to the handpiece hose
Selection of dry and wet work functions moved to foot control .
Addition of ultrasonic boost function to foot control ●
Addition of three operating modes with different ultrasonic power ranges . selectable from main scaler unit
Availability of three irrigation sources including two irrigation bottles and . external water supply

7. PERFORMANCE TESTING

The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and the completion of Design Control Checklists to ensure that all design requirements were fulfilled. The results confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Electro Medical Systems SA C/O Ms. Cynthia J. M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022328 Trade/Device Name: EMS Piezon® Master 600 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: July 17, 2002 Received: July 18, 2002

Dear Ms. Nolte:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Nolte

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cucinotta/Jr

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: EMS Piezon® Master 600

Indications for Use:

The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

Removing supra and subgingival calculus deposits and stains from teeth .
. Periodontal pocket lavage with simultaneous ultrasonic tip movement
. Scaling and root planing
. Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
. Plugging for amalgam condensation
. Amalgam burnishing
Preparing, cleaning and irrigating root canals ●
Cavity preparation .
Cementing inlays and onlays ●
. Retrograde preparation of root canals

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Allie Goehner for MSR

nesthesiology, General Hospital. arting Control Dental I

510(k) Number: K022328

Prescription Use
(Per 21 CFR 801.109)
✓

Over-The-Counter Use

(Optional Format 1-2-96)

July 17, 2002

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.